Impact of biomarker data: At most, approximately one third of U.S. and European neurologists surveyed cite a biomarker assessment (change from baseline on brain beta-amyloid load as assessed by an amyloid imaging agent at 18 months) as among the most persuasive end points that would convince them to prescribe a new disease-modifying therapy (DMT) for the treatment of mild to moderate Alzheimer's disease. Additionally, results of a conjoint study suggest that an effect on biomarkers (such as a reduction from baseline in brain beta-amyloid load, cerebrospinal fluid biomarkers for beta-amyloid and tau) has only a limited impact on the relative attractiveness of hypothetical future agents in the eyes of surveyed U.S. neurologists. In both cases, key clinical efficacy outcomes appear more compelling.

Hurdles for future DMTs: U.S. neurologists' projected patient shares for three Phase III emerging DMTs—Eli Lilly's solanezumab, Roche/Chugai/MorphoSys's gantenerumab and Merck's MK-8931—fall below those of emerging symptomatic agents tested, likely owing in part to a limited amount of supportive clinical data available and/or lingering questions about the validity of the amyloid hypothesis. Separately, data suggest that potentially sizable gains over donepezil (Eisai/Pfizer's Aricept, other brands, generics) would be required for a majority of surveyed U.S. managed care organization pharmacy directors to reimburse a new DMT that offered better efficacy on cognition and cost at least $30 per day—a substantial price premium over current clinical mainstays, which are mostly generically available.

"Interviewed neurologists express hope, but measured overall confidence, in the therapeutic potential of investigational DMTs, arguably the Holy Grail in this market. In the wake of repeated DMT failures, study findings reinforce our belief that novel agents that safely deliver even modest efficacy improvements—be they symptomatic or disease-modifying—will be well accepted into clinical practice."

"Aside from the obvious unmet need for therapeutic improvements in cognition and patient function, study data also signal a receptivity among clinician and payer respondents to agents that can safely address behavioral deficits in Alzheimer's disease, a largely untapped opportunity for drug developers in this arena."

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